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Effects of Probiotics on Oral Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444182
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
ABRAR ALANZI, Kuwait University

Brief Summary:
Some probiotics have been shown to have preventive effects on infectious diseases and allergies. Because their long-term enhancement of the immune responses of children, they have been recommended for infants in some countries. The most promising ones seem to be the combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic microbes are mainly ingested orally and the gastrointestinal tract is thus the primary target organ for them. However, the mouth is the first part of the gastrointestinal tract. Most probiotics are in theory cariogenic, thus their effects on oral health should be known. Several probiotics decrease levels of salivary mutans streptococci (MS), but in other respects very little is known about their effects on the oral microbiota. Also effects of probiotics on dental plaque should be studied. This study aims to find out the effects of the combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a mixture of them on the amount of plaque and gingival health

Condition or disease Intervention/treatment Phase
Periodontal Health Dental Plaque Accumulation Dietary Supplement: Probiotics Dietary Supplement: Placebo Phase 1 Phase 2

Detailed Description:

The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) have defined probiotics as "live micro-organisms, which when administered in adequate amounts, confer a health benefit to the host" (WHO 2002). They should preferably be of human origin, be able to temporarily colonize the gastrointestinal tract and survive in it. They must also be non-pathogenic and non-toxic.

Probiotics are used in the prevention and treatment of infectious diseases and allergies (Hatakka and Saxelin, 2008; Salminen et al., 2010). In some countries probiotics are recommended for infants and adults because of their long-term enhancement of the immune responses. Combinations of probiotics, like Bifidobacterium lactis BB-12 (BB-12) and Lactobacillus rhamnosus GG (LGG), appear to be most effective in this respect (Isolauri et al., 2000; Rautava et al., 2009; Smith et al., 2012). Probiotics are mainly ingested orally, and the gastrointestinal tract is thus the primary target organ for probiotic micro-organisms. However, when ingested in the form of for example tablets, chewing gums, cheese and milk, the oral cavity is exposed to the probiotics. With the world-wide increase in the use of probiotics their effects of on oral health have become a hot topic.

Many types of probiotic bacteria have been explored but the most widely studied species are those that belong to the genera Lactobacillus and Bifidobacterium. Yogurt and fermented milk products are considered the simplest source of probiotic administration for humans. The proven effects of probiotics in general health has led to more research in the oral health field including dental caries, periodontal disease and halitosis. Some clinical studies have demonstrated a decrease in the cariogenic mutans streptococci counts and in dental plaque (Näse et al. 2001, Ahola et al. 2002, Nikawa et al. 2004, Caglar et al. 2007, Twetman & Keller 2012). Probiotics have also shown improvements in the periodontal status in patients with periodontal disease (Riccia et al. 2007, Shimauchi et al. 2008, Teughels et al. 2013, Yanine et al. 2013). Recently, Toiviainen et al. (2015) found that the combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium strain Bifidobacterium lactis (BB-12) improved the periodontal health in healthy adults by reducing the plaque amount and subsequently the gingival inflammation without affecting the oral microbiota.

More evidence is necessary to confirm the efficacy of the combination of LGG and BB-12 in the oral health.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Lactobacillus Rhamnosus LGG and Bifidobacterium Lactis BB-12 on Gingival Health and Dental Plaque in Healthy Adolescents: a Randomized Controlled Clinical Trial
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Probiotics
participants will receive a lozenge containing mixture of probiotic bacteria BB-12 and LGG
Dietary Supplement: Probiotics
A half of the participants will be randomly allocated to the probiotics group. They will receive a probiotics lozenge twice a day for 4 weeks. Pre and Post intervention clinical exam will be conducted

Placebo Comparator: Control - No probiotics
Participants will receive a control lozenge containing no probiotics. all lozenges are sugar-free; sweetened by xylitol (0.5 g xylitol per piece)
Dietary Supplement: Placebo
A half of the participants will be randomly allocated to the placebo group. Lozenges with no probiotics will be given twice daily for 4 weeks. Pre and Post intervention clinical exam will be conducted




Primary Outcome Measures :
  1. Gingival Health [ Time Frame: Four weeks ]

    The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered.

    The criteria are:

    0 = no inflammation

    1. = mild inflammation, slight change in color, slight edema, no bleeding on probing
    2. = moderate inflammation, moderate glazing, redness, bleeding on probing
    3. = severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding

    The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four.

    The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined

    A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation


  2. Plaque Index [ Time Frame: four weeks ]

    A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque

    1. = separate flecks of plaque at the cervical margin of the tooth
    2. = a thin continuous band of plaque at the cervical margin
    3. = a band of plaque wider than 1 mm but covering less than 1/3 of the crown
    4. = plaque covering at least 1/3 but less than 2/3 of the crown
    5. = plaque covering 2/3 or more of crown

    An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined.

    ** Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)




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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adolescent - ASA I & II
  • No Antibiotics use
  • No intake of commercially available probiotics products during the intervention

Exclusion Criteria:

  • Adolescents have ASA III or IV
  • Antibiotics use
  • refuse to stop taking commercially available probiotics products during intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444182


Locations
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Kuwait
Abdullah Alwaheeb intermediate School
Kuwait, Kuwait, 13110
Sponsors and Collaborators
Kuwait University
University of Turku
Investigators
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Principal Investigator: ABRAR N ALANZI, MS KUWAIT UNIVERISTY
Publications of Results:
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Responsible Party: ABRAR ALANZI, ASSISTANT PROFESSOR, Kuwait University
ClinicalTrials.gov Identifier: NCT02444182    
Other Study ID Numbers: DD04/13
First Posted: May 14, 2015    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases